Inspection Readiness and EU-M4all Submission Support

Location:	District of Columbia
Posted:	Nov 24, 2025
Due:	Dec 19, 2025
Agency:	FHI 360
Type of Government:	State & Local
Category:	R - Professional, Administrative and Management Support Services
Solicitation No:	FY26 103470.2001.001-11-24-2025_RFP_02
Publication URL:	To access bid details, please log in.

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REQUEST FOR PROPOSAL (RFP)

Solicitation title:

Term of Contract:

This Procurement supports:

Submit Proposal to:

Date of Issue of RFP:

Date Questions Due:

Date Proposal Due:

Approximate Date Contract Issued:

Format of Submission:

Inspection Readiness and EU-M4all Submission Support

Approximately 2 years

Phase III Contraceptive Trial

Rachel Schultz, rschultz@fhi360.org

November 24, 2025

December 10, 2025

December 19, 2025

February 2026

Respond via e-mail with attached document in MS Word/Excel/pdf

format. The Offeror agrees to hold the prices in its proposal firm for 120

days from the date specified for the receipt of proposals, unless another

time is specified in the addendum of the RFP.

BACKGROUND:

FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by

advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition,

environment, economic development, civil society, gender, youth, research, technology,

communication, and social marketing—creating a unique mix of capabilities to address today’s

interrelated development challenges. FHI 360 serves more than 70 countries and all U.S. states and

territories.

FHI 360’s Contraceptive Research, Development and Introduction (CRDI) department strives to

accelerate wide access to quality, affordable and acceptable contraceptive products for those most in

need. In support of this goal, we are conducting a multi-country phase III contraceptive clinical trial

across 5 clinical sites. Next, we intend to seek a scientific opinion through the EU-M4all procedure. In

preparation for the EU-M4all procedure, we are seeking a contract research organization (CRO) to

support various inspection readiness and submission activities.

Inspection readiness activities: In order to ensure quality, integrity, and accuracy of all clinical trial data

within the EU-M4all regulatory dossier, we are seeking a CRO to perform rigorous mock inspections of

the clinical trial sites, analytical and clinical laboratories, manufacturer, and the electronic trial master

file (eTMF) and Sponsor organization. This CRO will verify adherence to Good Clinical Practice and train

study staff to manage stringent regulatory inspections. These simulated inspections and trainings will

prepare study site, vendor and sponsor staff for EMA/WHO PQ inspections and identify any gaps in

study documentation or processes, which will be followed by implementation of corrective action plans.

EU-M4all submission activities: In support of the submission to EUM4all of the dossier, we are seeking a

CRO to prepare EU-M4all-specific documents, compile the eCTD dossier in compliance with EMA

requirements, and submit to EMA via eSubmissions Gateway.

II. SCOPE OF WORK

It is anticipated that the selected Offeror will perform the following:

1: Inspection readiness activities

 Develop a detailed inspection readiness plan describing the strategy, timeline and roles and

responsibilities associated with mock inspection activities

 Conduct mock inspections of:

o 5 clinical trial sites, including local diagnostic laboratories, located in:

 Dominican Republic (1)

 United Kingdom (2)

 South Africa (1), and

 Chile (1)

o Sponsor (located in USA)

 including eTMF

o Central PK laboratory (located in USA)

o Vendors supporting the Phase 3 trial (3) located in the USA

o Clinical supplies logistics vendor (UK)

o Manufacturer (located in Indonesia)

 Verify adherence to GxP

 Train study sponsor, site and vendor staff to manage stringent regulatory inspections

 Coordinate discussions highlighting GCP compliance risks/areas for improvement identified

during assessments

 Complete mock inspection reports that provide detailed findings of the mock inspections and

corrective action plans; guide staff on adequacy of responses and corrective actions

 Maintain active communication with inspectees to address action items and issues

 Provide onsite QA lead to support actual EMA/WHO inspections as needed

 Assist in drafting corrective actions for actual EMA/WHO inspection findings

2: EU-M4all submission activities

 Provide regulatory project management support

 Support pre-submission activities, agency communications and meetings

 Develop pharmacovigilance system master file and prepare for post-opinion safety monitoring

 Develop the regulatory dossier in a standard 5-module eCTD format:

o Draft Modules 1 and 3

o Review and input on Modules 2, 4 and 5

 Preparation, assembly, publishing, and electronic submission of each component of the EU-

M4all dossier submission

III. OFFEROR QUALIFICATIONS

To be considered for this award, the Offeror must have:

 Experience with EMA inspections

 Experience with EMA regulatory submissions

IV. SUBMISSION DETAILS FOR TECHNICAL AND COST PROPOSAL

NOTE: Proposals that do not include all of the following components may NOT be considered.

V.1. Technical Proposal

To be considered, the Technical Proposal should show an understanding of the RFP requirements and make

clear the Offeror’s value proposition.

The proposal should include but is not limited to the following:

 Corporate Profile highlighting the Offeror’s qualifications and experience in implementing the

assignment, please include details of specific experience with similar assignments in the past five years.

Specifically, the following should be answered in your submission:

 Experience with EU-M4all:

o How many EU-M4all submissions have you supported?

o How many EMA marketing authorization submissions (centralized procedure) have you

supported?

o What was your CRO’s specific role for the submissions and can you provide references?

 Experience with inspection readiness:

o How many EMA inspections have you supported in the past 5 years for various programs

(specify types of inspections/products)?

o How do you prepare staff and sites for EMA inspections?

o Can you provide references from sponsors with EMA-inspected trials?

 Methodology/approach to project demonstrating how you meet or exceed requirements for this

assignment

 Proposed timeline and milestones

 Details of the Proposed Team for the assignment including the following information:

o Title/Designation of each team member on the project

o Educational qualifications and professional experiences

o Past experience in working on similar project and assignment

Offerors are requested to back up their submissions by providing:

 Three examples/case studies of relevant and similar past performance containing the following

information:

▪ Name of Client

▪ Title of the Project

▪ Year and duration of the project

▪ Scope of the Projects/Requirements

▪ Proposed Solutions and Outcome – include visuals, web-links, etc.

▪ Team members on each of the project and their specific roles

▪ Project timelines (start and end date year, and any other information necessary)

▪ Reference /Contact person details

Offeror’s proposal must include an email address so that FHI 360 may send, at its discretion, a confirmation of

receipt of your submission.

V.2. Cost Proposal

Please submit a distinct cost proposal in an Excel Spreadsheet with a summary and detailed budget. All

quotes must be in US Dollars.

Also, Offerors must submit a Budget Narrative, providing information on how unit costs and numbers of units

were calculated. Discuss applied discounts and other approaches to justify cost reasonableness and achieve

cost efficiency.

V. EVALUATION CRITERIA FOR REVIEW OF PROPOSAL:

Proposals will be evaluated and ranked by a committee on a best value basis. For the purpose of this

RFP, cost, delivery, technical and past performance are of equal importance. FHI 360 intends to evaluate

offers and award a contract without discussions with Offerors.

VI. INSTRUCTIONS AND DEADLINE:

Tentative timeline:

RFP posted:

Proposal submission deadline:

Anticipated Award Start Date:

November 24, 2025

December 19, 2025

February 2026

All requests for clarification or questions on this request for proposals must be sent by email to Rachel

Schultz at rschultz@fhi360.org no later than December 10, 2025 at 5:00 pm (EST) Eastern Standard

Time.

Proposals must be submitted by email to Rachel Schultz at rschultz@fhi360.org no later than December

19, 2025 at 5:00 pm (EST) Eastern Standard Time. Proposals received after the date and time indicated

may not be accepted. FHI 360 may acknowledge receipt of the response by email. The proposal must be

submitted in electronic format using software compatible with Microsoft Office.

Financial pre-assessment and determination of responsibilities

Upon the review of selected proposals, FHI 360 will work with the selected Offeror(s) to develop a

subcontract.

FHI 360 will perform a Due-Diligence Questionnaire (DDQ) or Pre-Award Assessment (PAT) on the

selected organization(s) to ensure that the subcontract is awarded only to an organization(s) that has

the capacity to adequately perform in accordance with the terms and conditions laid out in the

subcontract per FHI 360’s requirements and regulations. The DDQ/PAT will be a preliminary step in the

subcontracting process. The assessment will be conducted on the organization’s financial,

administrative, and risk management systems to ensure that they are in place and sufficient. FHI 360 will

not award a subcontract to any organization whose internal controls, financial management, and

reporting processes are determined to be poor in accounting for funds. Pre-Award surveys for

determination and findings of responsibility will be conducted at this phase, and may involve a desk

review, on-site assessment, or both.

Withdrawal of Proposals

Proposals may be withdrawn by written notice, email or facsimile received at any time before award.

False Statements in Offer

Offerors must provide full, accurate and complete information as required by this solicitation and its

attachments.

DISCLAIMERS AND FHI 360 PROTECTION CLAUSES

 FHI 360 will not compensate the individual for its preparation of response to this RFP.

 Proposals become property of FHI 360 .

 FHI 360 may cancel the solicitation and not make an award

 FHI 360 may reject any or all responses received

 Issuance of a solicitation does not constitute an award commitment by FHI 360

 FHI 360 reserves the right to disqualify any offer based on offeror failure to follow solicitation

instructions

 FHI 360 will not compensate offers for response to solicitation

 FHI 360 reserves the right to issue an award based on initial evaluation of offers without further

discussion

 FHI 360 may choose to award only part of the activities in the solicitation, or

issue multiple awards based on the solicitation activities

 FHI 360 may request from short-listed offerors a second or third round of either oral presentation or

written response to a more specific and detailed scope of work that is based on a general scope of

work in the original RFP.

 FHI 360 has the right to rescind an RFP or rescind an award prior to the signing of a subcontract due

to any unforeseen changes in the direction of FHI 360’s client, be it funding or programmatic.

 FHI 360 reserves the right to waive minor proposal deficiencies that can be

corrected prior to award determination to promote competition

 FHI 360 may be contacting Offerors to confirm contact person, address and that proposal was

submitted for this solicitation.

******END OF RFP******

This is the opportunity summary page. It provides an overview of this opportunity and a preview of the attached documentation.

Inspection Readiness and EU-M4all Submission Support

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